# K991257: Fuji Wavelet Compression or Ffcomp Irreversible Compression

- Pathway: 510(k) (Traditional)
- Applicant: Fujifilm Medical System U.S.A., Inc.
- Decided: Jun 25, 1999 after 73 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K931002 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972256: FCR Fuji Computed Radiography DMS CRT Image Console HI-C654 (for Networks), Fujifilm Medical System U.S.A., Inc. (1997) Summary page 1.

## Recalls of this device
- May 12, 2003 · Not classified · Z-0932-03: Synapse Version 2.2.1 and 2.3.1 Software [Free-Hand Region] may lead to incorrect density calculations during CT scan

## Indications for use
Fuji wavelet compression is intended to be used in applications to compress digital medical image data.

Source page: https://510kreport.com/device/K991257
Methodology: https://510kreport.com/methodology